Healthy SubjectsPhase 1NCT07256600
PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers
A Phase 1 study testing DWJ1445 and DWC202506 in people with Healthy Subjects, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- DWJ1445 and DWC202506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2025to 2 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with a body mass index (BMI) between 18 and 30 kg/m²
- Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
- Subjects who agree to use a medically acceptable method of contraception
Who cannot join
- Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
- Subjects with a history of gastrointestinal surgery that may affect drug absorption
- Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence After Administration of "DWJ1445" and "DWC202506" in Healthy Adults
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
Read the detailed description
This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
- Conditions
- Healthy Subjects
- Being tested
- DWJ1445, DWC202506
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1445Drug
1 tablet, Orally
DWC202506Drug
1 tablet, Orally
| Study group | Role | What they receive |
|---|---|---|
| A(RT) | Experimental | 35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2 Receives: Drug: DWJ1445; Drug: DWC202506 |
| B(TR) | Experimental | 35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2 Receives: Drug: DWJ1445; Drug: DWC202506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve [AUCt] of DWJ1445 and DWC202506
Measured: 0-24 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of DWJ1445 and DWC202506
Measured: 0-24 hours
Secondary outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of DWJ1445 and DWC202506
Measured: 0-24 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of DWJ1445 and DWC202506
Measured: 0-24 hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Amoxicillin \& Clavulanic acid of DWJ1445 and DWC202506
Measured: 0-24 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life of DWJ1445 and DWC202506
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start14 Nov 2025
- Primary completion23 Nov 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256600
- Sponsor's protocol ID
- DW_DWJ1445102
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence After Administration of "DWJ1445" and "DWC202506" in Healthy Adults
- ClinicalTrials.gov ID
- NCT07256600
- Acronym / sponsor ID
- DW_DWJ1445102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
Detailed description
This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(RT) | Experimental | Drug: DWJ1445, Drug: DWC20250635 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2 |
| B(TR) | Experimental | Drug: DWJ1445, Drug: DWC20250635 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects with a body mass index (BMI) between 18 and 30 kg/m²
- Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
- Subjects who agree to use a medically acceptable method of contraception
Key exclusion criteria (3 listed)
- Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
- Subjects with a history of gastrointestinal surgery that may affect drug absorption
- Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWJ14451 tablet, Orally | Drug | A(RT), B(TR) |
| DWC2025061 tablet, Orally | Drug | A(RT), B(TR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-24 hours
Area under the plasma drug concentration-time curve [AUCt] of DWJ1445 and DWC202506
Maximum plasma concentration [Cmax]
Time frame: 0-24 hours
Maximum plasma concentration [Cmax] of DWJ1445 and DWC202506
4 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity
Time frame: 0-24 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
Time frame: 0-24 hours
Time of peak concentration [Tmax]
Time frame: 0-24 hours
Terminal phase of half-life [t1/2]
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWJ1445 and DWC202506 in people with Healthy Subjects, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma drug concentration-time curve [AUCt] (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.